myLAB Box COVID-19 At-Home Viral Detection Test

The myLAB Box P23 COVID-19 At-Home Test offers a convenient and safe way for people to test for COVID-19 infection. The test uses a non-invasive self-collected saliva sample. Self-collection of saliva is painless and reduces the risk of spreading COVID-19, compared to collecting deep nasal swabs in a doctor’s office or hospital.

The test kit was developed by a CLIA-certified high complexity clinical laboratory capable of large volume testing. The lab uses gold standard PCR to detect the COVID-19 virus, if present. The accuracy of this test has been validated and is authorized by the FDA under an Emergency Use Authorization (EUA).

You will need to complete the myLAB Box medical questionnaire prior to check out. Upon receipt of your kit in the mail, collect your sample following the instructions provided, register your kit using myLAB Box’s secure HIPAA-compliant portal. You’ll then collect your sample following the instructions provided in the kit and send your sample to the lab using the prepaid overnight return envelope provided in the kit. You can now find the MLB# on the tube itself. For more details, please refer to the myLAB Box P23 At-Home COVID-19 Test Collection Kit Saliva – Unsupervised – Instructions for Patients.

If you have any symptoms of a serious COVID-19 infection such as difficulty breathing or shortness of breath, persistent pain or pressure in the chest, new confusion or inability to arouse or bluish lips or face, please do NOT order a test for COVID-19. Please instead contact your healthcare provider immediately, and failing to reach them, go to the nearest emergency room or dial 911 for medical assistance.

IMPORTANT NOTICE: If you are experiencing symptoms such as shortness of breath (you are having trouble breathing) or a fever greater than 100.4 you should go to your doctor, nearest urgent care or call 911. Do not order this test.

Included: 1 mail-in saliva specimen collection kit

• Screen for coronavirus (COVID-19)
• Mail-in kit for home use
• Viral detection test using saliva sample
• Gold standard PCR technology
• Simple collection in 5 minutes or less
• Results in as little as 24 hours
• Free physician consult for positives
• Free overnight shipping included
• FDA authorized

Fact Sheets

• Fact Sheet for Healthcare Providers
• Fact Sheet for Patients

DISCLAIMER This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for the detection of nucleic acid from SARSCoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. This test uses the P23 Labs TaqPath SARS-CoV-2 Assay.